Qualification and validation

As a supplier of packaging lines for the pharmaceutical industry, Schubert-Pharma offers validation services based on years of experience. Our GMP-compliant validation package can be tailored to individual needs, and is extremely effective and time-saving. Schubert-Pharma is pleased to support its customers in carrying out validation activities within the scope of line acceptance – either at our factory or on site following installation.

Service packages in the field of validations

The following modules are available:

  • GMP risk analysis (including workshop with customers)
  • Functional specification
  • Hardware specification
  • Software specification
  • Factory Acceptance Test (FAT) protocol (includes critical IQ and OQ elements)
  • Site Acceptance Test (SAT) protocol (includes critical IQ and OQ elements)
  • Installation Qualification (IQ) and Operational Qualification (OQ)
  • Traceability Matrix
We will be happy to support you in carrying out validation activities within the scope of line inspections – either at our factory or on site following installation.